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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC. GLIDESCOPE TITANIUM LO-PRO T4; VIDEO LARYNGOSCOPE
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VERATHON MEDICAL ULC. GLIDESCOPE TITANIUM LO-PRO T4; VIDEO LARYNGOSCOPE Back to Search Results
Model Number LO-PRO T4
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2015
Event Type  malfunction  
Event Description
The glidescope titanium lo-pro t3 blade was found to have a sharp edge with small burrs on it upon initial inspection by the customer.No pt involvement was reported.
 
Manufacturer Narrative
Device eval summary: confirmed small burrs causing a sharp edge on the side of the blade.No repairs available.These types of complaints are being actively tracked and investigated.Further action will be taken as necessary.
 
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Brand Name
GLIDESCOPE TITANIUM LO-PRO T4
Type of Device
VIDEO LARYNGOSCOPE
Manufacturer (Section D)
VERATHON MEDICAL ULC.
burnaby, bc
CA 
Manufacturer (Section G)
VERATHON MED ULC
2227 douglas rd
burnaby, bc V5C 5A9
CA   V5C 5A9
Manufacturer Contact
brian blakeslee
20001 n creek pkwy
bothell, WA 98011
8003312313
MDR Report Key4874278
MDR Text Key5860381
Report Number9615393-2015-00055
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLO-PRO T4
Device Catalogue Number0574-147
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/22/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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